Active Ingredient (In Each Tablet)
Acteminophen 500 mg
Acetaminophen 500mg Tablet
FDA Label NDC 69168-011
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Allegiant Health for the product Acetaminophen 500mg (NDC 69168-011). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each tablet), purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Pain reliever/fever reducer
Uses
temporary relief of minor aches and pains associated with
- common cold
- headache
- toothache
- muscular aches
- backache
- arthritis
- menstrual cramps
- temporarily reduces fever
Warnings
Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
- skin reddening
- blisters
- rash
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
Do Not Use
- if you are allergic to acetaminophen
- with any other drug containing acetaminophen (prescription or nonprescription).
If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Ask A Doctor Before Use If You Have
liver disease
Ask A Doctor Or Pharmacist Before Use If You Are
taking the blood thinning drug warfarin.
Stop Use And Ask A Doctor If
- symptoms do not improve
- pain gets worse or lasts for more than 10 days
- pain get worse or lasts more than 5 days in children under 12 years
- fever gets worse or lasts for more than 3 days
- new symptoms occur
- redness or swelling is present
- a rare sensitivity reaction occurs
- You may report side effects to 1-888-952-0050
If Pregnant Or Breast-Feeding
If pregnant or breast-feeding, ask a health professional before use.
Keep Out Of Reach Of Children
Keep out of reach of children. In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
- do not use more than directed (see overdose warning)
- adults and children 12 years and over: take 2 tablets every 4 to 6 hours. Do not take more than 8 tablets in 24 hours.
- Do not use more than 10 days unless directed by a doctor
- children under 12 years of age: do not use this extra strength product; this will provide more than the recommended dose (overdose) and could cause serious health problems.
Other Information
- store between 20°-25°C (68°-77°F)
- do not use if imprinted safety seal under cap is broken or missing
Inactive Ingredients
corn starch, povidone, pregelatinized starch, sodium starch glycolate, stearic acid
Principal Display Panel
Acetaminophen 500mg (011 Health A2z Acetaminophen 500mg 1)
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